[Federal Register Volume 69, Number 228 (Monday, November 29, 2004)]
[Rules and Regulations]
[Pages 69320-69325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26071]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[OAR-2003-0188; FRL-7841-8]
RIN 2060-AL87
List of Hazardous Air Pollutants, Petition Process, Lesser
Quantity Designations, Source Category List; Petition To Delist of
Ethylene Glycol Monobutyl Ether
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The EPA is amending the list of hazardous air pollutants (HAP)
contained in section 112(b)(1) of the Clean Air Act (CAA) by removing
the compound ethylene glycol monobutyl ether (EGBE) (2-Butoxyethanol)
(Chemical Abstract Service (CAS) No. 111-76-2) from the group of glycol
ethers. This action is being taken in response to a petition to delete
EGBE from the HAP list submitted by the Ethylene Glycol Ethers Panel of
the American Chemistry Council (ACC) (formerly the Chemical
Manufacturers Association) on behalf of EGBE producers and consumers.
Petitions to delete a substance from the HAP list are permitted under
section 112(b)(3) of the CAA.
Based on the available information concerning the potential hazards
of and projected exposures to EGBE, EPA has made a determination
pursuant to CAA section 112(b)(3)(C) that there are ``adequate data on
the health and environmental effects [of EGBE] to determine that
emissions, ambient concentrations, bioaccumulation, or deposition of
the substance may not reasonably be anticipated to cause adverse
effects to human health or adverse environmental effects.''
DATES: Effective November 29, 2004.
ADDRESSES: The EPA has established a docket for this action under
Docket ID No. OAR-2003-0188 and A-99-24. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the EPA Docket Center (Air Docket), EPA/
DC, EPA West, Room B-102, 1301 Constitution Avenue, NW, Washington, DC
10460. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the Public Reading Room is (202) 566-1744, and the telephone number
for the Air Docket is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: Ms. Kelly Rimer, Office of Air Quality
Planning and Standards, Emission Standards Division, C404-01, U. S.
EPA, Research Triangle Park, NC 27711; telephone number: (919) 541-
2962; fax number: 919-541-0840; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION: Regulated Entities. Entities potentially
affected by this action are those industrial facilities that
manufacture or use EGBE. The final rule amends the list of HAP
contained in section 112(b)(1) of the CAA by removing the compound
EGBE. The decision to issue a final rule to delist EGBE removes EGBE
from regulatory consideration under section 112(d) of the CAA.
Judicial Review. Under section 307(b)(1) of the CAA, judicial
review is available only by filing a petition for review in the U.S.
Court of Appeals for the District of Columbia Circuit by 60 days from
publication in the Federal Register. Under section 307(d)(7)(B) of the
CAA, only an objection to a rule or procedure raised with reasonable
specificity during the period for public comment can be raised during
judicial review. Moreover, under section 307(b)(2) of the CAA, the
requirements established by the final rule may not be challenged
separately in any civil or criminal proceeding brought to enforce these
requirements.
Outline. The information presented in this preamble is organized as
follows:
I. Introduction
A. The Delisting Process
B. The Present Petition and Rulemaking
II. Peer Review of New Data on EGBE Metabolite, Butoxyacetaldehyde
III. Public Comments on Proposed Rule to Delist EGBE
IV. Final Rule
A. Rationale for Action
B. Effective Date
V. References
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Analysis
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children from
Environmental Health & Safety Risks
H. Executive Order 13211: Actions that Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Congressional Review Act
I. Introduction
A. The Delisting Process
Section 112 of the CAA contains a mandate for EPA to evaluate and
control emissions of HAP. Section 112(b)(1) includes an initial list of
HAPs that are composed of specific chemical compounds and compound
classes to be used by EPA to identify source categories for which EPA
will subsequently promulgate emissions standards.
Section 112(b)(2) of the CAA requires EPA to make periodic
revisions to the initial list of HAPs set forth in section 112(b)(1)
and outlines criteria to be applied in deciding whether to add or
delete particular substances. Section 112(b)(2) identifies pollutants
that should be listed as: `` * * * pollutants which present, or may
present, through inhalation or other routes of exposure, a threat of
adverse human health effects (including, but not limited to, substances
which are known to be, or may reasonably be anticipated to be
carcinogenic, mutagenic, teratogenic, neurotoxic, which cause
reproductive dysfunction, or which are acutely or chronically toxic) or
adverse environmental effects whether through ambient concentrations,
bioaccumulation, deposition, or otherwise. * * * ''
To assist EPA in making judgements about whether a pollutant causes
an adverse environmental effect, section 112(a)(7) defines an ``adverse
environmental effect'' as: ``* * * any significant and widespread
adverse effect, which may reasonably be anticipated, to wildlife,
aquatic life, or other natural resources, including adverse impacts on
populations of endangered or threatened species or significant
degradation of environmental quality over broad areas.''
Section 112(b)(3) establishes general requirements for petitioning
EPA to modify the HAP list by adding or deleting a substance. Although
the Administrator may add or delete a substance on his or her own
initiative, the burden is on a petitioner to include sufficient
information to support the
[[Page 69321]]
requested addition or deletion under the substantive criteria set forth
in CAA section 112(b)(3)(B) and (C). The Administrator must either
grant or deny a petition within 18 months of receipt of a complete
petition. If the Administrator decides to grant a petition, the Agency
publishes a written explanation of the Administrator's decision, along
with a proposed rule to add or delete the substance. If the
Administrator decides to deny the petition, the Agency publishes a
written explanation of the basis for denial. A decision to deny a
petition is final Agency action subject to review in the D.C. Circuit
Court of Appeals under CAA section 307(b).
To promulgate a final rule deleting a substance from the HAP list,
CAA section 112(b)(3)(C) provides that the Administrator must determine
that there are: '' * * * adequate data on the health and environmental
effects of the substance to determine that emissions, ambient
concentrations, bioaccumulation, or deposition of the substance may not
reasonably be anticipated to cause any adverse effects to the human
health or adverse environmental effects.''
The EPA will grant a petition to delete a substance and publish a
proposed rule to delete that substance, if it makes an initial
determination that these criteria have been met. After affording an
opportunity for comment and for a hearing, EPA will make a final
determination whether the criteria have been met.
The EPA does not interpret CAA section 112(b)(3)(C) to require
absolute certainty that a pollutant will not cause adverse effects on
human health or the environment before it may be deleted from the list.
The use of the terms ``adequate'' and ``reasonably'' indicate that the
Agency must weigh the potential uncertainties and their likely
significance. Uncertainties concerning the risk of adverse health or
environmental effects may be mitigated if EPA can determine that
projected exposures are sufficiently low to provide reasonable
assurance that such adverse effects will not occur. Similarly,
uncertainties concerning the magnitude of projected exposure may be
mitigated if EPA can determine that the levels which might cause
adverse health or environmental effects are sufficiently high to
provide reasonable assurance that exposures will not reach harmful
levels. However, the burden remains on a petitioner to resolve any
critical uncertainties associated with missing information. The EPA
will not grant a petition to delete a substance if there are major
uncertainties which need to be addressed before EPA would have
sufficient information to make the requisite determination.
B. The Present Petition and Rulemaking
On August 29, 1997, the ACC's Glycol Ethers Panel submitted a
petition to delete EGBE (CAS No. 111-76-2) from the HAP list in CAA
section 112(b)(1), 42 U.S.C. 7412(b)(1). Following the receipt of the
petition, we conducted a preliminary evaluation to determine whether
the petition was complete according to Agency criteria. To be deemed
complete, a petition must consider all available health and
environmental effects data. A petition must also provide comprehensive
emissions data, including peak and annual average emissions for each
source or for a representative selection of sources, and must estimate
the resulting exposures of people living in the vicinity of the
sources.
In addition, a petition must address the environmental impacts
associated with emissions to the ambient air and impacts associated
with the subsequent cross-media transport of those emissions. After
receiving additional submittals through December 21, 1998, we
determined the petition to delete EGBE to be complete. We published a
notice of receipt of a complete petition in the Federal Register on
August 3, 1999 and requested information to assist us in technically
reviewing the petition.
We received eight submissions in response to our request for
comment and information which would aid our technical review of the
petition. The comments made general statements encouraging EPA to
delist EGBE. None of the comments included technical information.
On November 4, 2003, based on a comprehensive review of the data
provided in the petition and otherwise provided to EPA, the Agency made
an initial determination that the statutory criteria for deletion of
EGBE from the HAP list had been met. The EPA, therefore, granted the
petition by the ACC's Glycol Ethers Panel and issued a proposed rule to
delist EGBE (68 FR 65648, November 21, 2003).
The EPA received a total of 18 comments on the November 21, 2003
proposed rule. While three of the commenters opposed deleting EGBE from
the HAP list, they provided no substantive arguments to support this
position. There was no request for a public hearing.
The EPA's decision to remove EGBE from the list of HAP is based on
the results of a risk assessment demonstrating that emissions of EGBE
may not reasonably be anticipated to result in adverse human health or
environmental effects. In addition to the risk assessment, we have
considered public comments, as well as other information related to
EGBE in making this decision, namely the transformation of EGBE into
other HAP as it decomposes in the ambient air. We conclude that ambient
concentrations of the transformed HAP are very small, and that they
decompose rapidly. Therefore, we do not anticipate that EGBE
transformation will be significant enough to have an adverse impact on
human health.
We also considered the fact that EGBE is reported to the Toxics
Release Inventory (TRI) as part of the group of glycol ethers. The 2000
TRI shows the air emissions of the class of chemicals ``Certain Glycol
Ethers'' to be ranked number 12 by volume. Under the final rule, it
will no longer be regulated as a HAP, but it will continue to be
reported in the TRI, as part of the group ``Certain Glycol Ethers'' and
regulated under EPA's criteria pollutant (ozone) program.
The EPA has made a final determination, after careful consideration
of the petition and after completing additional analyses, that there
are adequate data on the health and environmental effects of EGBE to
determine that emissions, ambient concentrations, bioaccumulation, or
deposition of EGBE may not reasonably be anticipated to cause any
adverse effects to the human health or adverse environmental effects.
II. Peer Review of New Data on EGBE Metabolite, Butoxyacetaldehyde
In the preamble to the proposed rule, we stated that the Agency
believes EGBE is not genotoxic and that two distinctly different
nonlinear modes of action are principally responsible for the increased
forestomach and liver tumors reported by NTP (2000a). These modes of
action are discussed in detail in the Interim Final position paper,
``An Evaluation of the Human Carcinogenic Potential of Ethylene Glycol
Butyl Ether,'' available from the Docket for the final rule. We also
stated that there are reports of weak positive effects by EGBE at high
concentrations in some in vitro assays which may indicate the potential
for genotoxicity by butoxyacetaldehyde (BAL), an EGBE metabolite known
to cause clastogenic changes at high in vitro concentrations (see the
section on ``Other Possible Modes of Action for Forestomach Tumor
Development in Female Mice'' in the Agency's position paper). However,
available evidence from a published EGBE physiologically based
pharmacokinetic model that had
[[Page 69322]]
been modified to include kinetics for the metabolism of the BAL
intermediate (Corley, 2003) suggested that the concentrations of BAL
metabolite predicted to occur in vivo would be much lower than the
concentrations used in the in vitro assays. Based on this, it appears
that genotoxicity is not a factor in tumor development in female mice.
This increases our confidence that a nonlinear mechanism is involved in
tumor formation (versus a linear mechanism which would be suggested if
genotoxicity was involved). As we discussed in the preamble to the
proposed rule, additional research (e.g., verification of these PBPK
modeling results and further genotoxicity research using more
appropriate assays and currently accepted test protocols) would be
beneficial to provide a more definitive determination regarding the
role of BAL in the formation of forestomach tumors in female mice.
Since the publication of the proposed rule, additional research has
been completed and submitted to EPA. Subsequently, we commissioned a
peer review panel to evaluate the new data submitted and EPA's
conclusions of the proposed ruling and interim final position paper in
light of the recent research and literature that has been submitted to
the Agency in response to the Agency's proposed EGBE ruling. The peer
review was conducted on May 19, 2004 by an external review panel of
seven experts. A report on the results of this peer review is included
in the docket for the final rule. In summary, the peer review panel was
unanimous in agreeing that there is enough information to support an
informed decision concerning the significance of BAL genotoxicity to
the formation of EGBE induced liver and forestomach tumors. The
available information support a nonlinear mode of action, not a linear
mode of action (e.g., genotoxicity) for the male mouse liver tumors and
female mouse forestomach tumors observed following EGBE exposure. That
is, the reviewers concluded that genotoxicity is not important in the
development of these tumors.
The panel also concluded that it is reasonable to expect that a
lack of hemolytic effects in humans would preclude the formation of
liver tumors in humans and that a lack of hyperplastic effects in the
region of the gastroesophogeal junction in humans would preclude the
formation of gastrointestinal tumors in humans. That is, the data
support the finding that we would not expect to find these tumors in
humans following environmental exposures. The RfC and RfD values for
EGBE have been set at levels that prevent both the precursor events
that would lead to tumors and other noncancer effects, and the Agency
has determined that exposures to EGBE are at levels well below the RfC
and RfD. We can therefore conclude with confidence that emissions,
ambient concentrations, bioaccumulation, or deposition of EGBE may not
reasonably be anticipated to cause any adverse effects to the human
health.
III. Public Comments on Proposed Rule To Delist EGBE
Of the 18 written comments we received pertaining to the proposed
delisting of EGBE, 15 were supportive of the decision to delist and 3
opposed the decision to delist.
The EPA has considered carefully all the comments both supporting
and opposing the proposed delisting. A summary of the comments and EPA
responses to them has been included in the docket for this proceeding.
We received substantive comments with regard to the BAL issue, which we
discussed in detail above. We received no substantive negative
comments. Two of the comments in support of the delisting also asked
specific policy questions. We respond to those questions below.
Comment: One commenter asked if the rule also applies to diethylene
glycol monobutyl ether (DEGBE). The commenter expressed support for
delisting both chemicals in the rule.
Response: The final rule applies only to EGBE, one of the compounds
included in the group of glycol ethers listed in the section 112(b)(1)
HAP list. The petition requested that one single compound, EGBE, be
delisted; it did not request EPA to consider removing any other
compounds in the group of glycol ethers. Therefore this action pertains
only to EGBE.
Comment: One commenter urged EPA to address the ``Once In, Always
In'' policy in the final rulemaking for facilities that will no longer
be major sources for MACT standards once EGBE is delisted. This
commenter requested that the ``Once In, Always In'' policy not apply to
delistings in general, since a facility that was only over the major
source threshold due to emissions of a subsequently delisted HAP may
never have been a ``major source'' from a health perspective, and
therefore never really ``in''. The commenter argued that the purpose of
the policy that sources not be allowed to backslide from MACT
standards, is not applicable to delistings because in such cases the
health and environmental protection of a standard is not undermined
since the delisted chemical has been determined not to be a health and
environmental threat.
Response: This action addresses a request to remove a specific
pollutant from the HAP list. Any questions about the ``Once In Always
In Policy'' are beyond the scope of today's action. The EPA will
address the ``Once In Always In Policy'' in the future.
IV. Final Rule
A. Rationale for Action
The detailed factual rationale for supporting the Agency's initial
determination that the criteria in Clean Air Act section 112(b)(3)(C)
had been met is set forth in the proposed rule published in the Federal
Register on November 21, 2003 (68 FR 65648). However, as described
above, EPA received additional data during the public comment period
and had those data peer reviewed. The results of the peer review
strengthen the case for delisting. The EPA also received 18 public
comments on the proposed rule, none of which caused EPA to revise the
scientific basis upon which the initial determination to delist EGBE
was predicated. The EPA hereby incorporates into its rationale for the
final rule the substantive assessment of potential hazards, projected
exposures, human risk, and environmental effects set forth in the
proposed rule to delist EGBE. Based on that assessment, the Agency's
evaluation of the comments, and additional information submitted during
the rulemaking (as summarized above), EPA has made a determination that
there are adequate data on the health and environmental effects of EGBE
to determine that emissions, ambient concentrations, bioaccumulation,
or deposition of the compound may not reasonably be anticipated to
cause adverse human health or environmental effects.
B. Effective Date
The final rule will be effective on November 29, 2004, the date it
is published in the Federal Register. Although Section 553(d) of the
Administrative Procedures Act, 5 U.S.C. 553(d), provides that
substantive rules must be published at least 30 days prior to their
effective date, this requirement does not apply to this action. First,
the rule was promulgated pursuant to CAA section 307(d), and that
provision expressly states that the provisions of section 553 do not
apply to this action. Second, even under section 553, the requirement
that a rule be published 30 days prior to its effective date does not
apply to a rule, ``which grants or
[[Page 69323]]
recognizes an exemption or relieves a restriction.''
V. References
References cited in the preamble can be viewed in the docket for
the final rule.
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA
must determine whether the regulatory action is ``significant'' and
therefore subject to Office of Management and Budget (OMB) review and
the requirements of the Executive Order. The Executive Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adverse affect in a material way the economy, a sector to the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligation of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that the final action does not constitute a ``significant
regulatory action'' and is, therefore, not subject to OMB review.
B. Paperwork Reduction Act
This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
The final action will remove EGBE from the CAA section 112 (b)(1) HAP
list and, therefore, eliminate the need for information collection
under the CAA. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information. An Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
C. Regulatory Flexibility Act (RFA)
The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small business, small organizations, and small
governmental jurisdictions. For the purposes of assessing the impacts
of today's final rule on small entities, small entity is defined as:
(1) A small business that meets the definitions for small business
based on the Small Business Association (SBA) size standards which, for
this final action, can include manufacturing (NAICS 3999-03) and air
transportation (NAICS 4522-98 and 4512-98) operations that employ less
1,000 people and engineering services (NAICS 8711-98) operations that
earn less than $20 million annually; (2) a small governmental
jurisdiction that is a government of a city, county, town, school
district or special district with a population of less than 50,000; and
(3) a small organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
After considering the economic impact of today's final rule on
small entities, I certify that this final action will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analysis is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the final rule on small entities.'' (5 U.S.C. 603
and 604). Thus, an agency may certify that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on all of the small entities subject to the rule. The
final rule will eliminate the burden of additional controls necessary
to reduce EGBE emissions and the associated operating, monitoring and
reporting requirements. We have, therefore, concluded that today's
final rule will relieve regulatory burden for all small entities. We
continue to be interested in the potential impacts of the final rule on
small entities and welcome comments on issues related to such impacts.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 1044, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for final and final rules with ``Federal mandates'' that may
result in expenditures to State, local, and tribal governments, in the
aggregate, or to the private sector, of $100 million or more in any 1
year. Before promulgating an EPA rule for which a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
Today's final rule contains no Federal mandates for State, local,
or tribal
[[Page 69324]]
governments or the private sector. The final rule imposes no
enforceable duty on any State, local or tribal governments or the
private sector. The EPA has determined that the final rule does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. Because the final rule
removes a compound previously labeled in the CAA as a HAP, it actually
reduces the burden established under the CAA. Thus, today's final rule
is not subject to the requirements of sections 202 and 205 of the UMRA.
E. Executive Order 13132, Federalism
Executive Order 13132 (64 FR 43255, August 10, 1999) requires to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.''
Under Executive Order 13132, EPA may not issue a regulation that
has federalism implications, that imposes substantial direct compliance
costs, and that is not required by statute, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by State and local governments, or EPA consults with
State and local officials early in the process of developing the final
regulation. The EPA also may not issue a regulation that has federalism
implications and that preempts State law unless the Agency consults
with State and local officials early in the process of developing the
final regulation.
Today's final rule removes the substance EGBE from the list of HAP
contained under section 112(b)(1) of the CAA. It does not impose any
additional requirements on the States and does not affect the balance
of power between the States and the Federal government. Thus, the
requirements of section 6 of the Executive Order do not apply to the
final rule.
F. Executive Order 13175, Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' The final rule does not have
tribal implications, as specified in Executive Order 13175. The final
rule will eliminate control requirements for EGBE and, therefore,
reduces control costs and reporting requirements for any tribal entity
operating a EGBE source subject to control under the CAA. Thus,
Executive Order 13175 does not apply to the final rule.
G. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, the Agency must evaluate the environmental health or
safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under section 5-501 of the Executive Order has
the potential to influence the regulation. The final rule is not
subject to Executive Order 13045 because it is not economically
significant as defined in Executive Order 12866, and because the Agency
does not have reason to believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children. This determination is based on the fact that the RfC is
determined to be protective of sensitive sub-populations, including
children.
H. Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
Executive Order 13211, ``Actions Concerning Regulations that
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), requires EPA to prepare and submit a Statement of
Energy Effects to the Administrator of the Office of Information and
Regulatory Affairs, Office of Management and Budget, for certain
actions identified as ``significant energy actions.'' The final rule is
not a ``significant energy action'' because it is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy.
I. National Technology Transfer and Advancement Act
Section 112(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law No. 104-113, section 12(d) 915 U.S.C.
272 note), directs all Federal agencies to use voluntary consensus
standards instead of government-unique standards in their regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., material specifications, test method, sampling and
analytical procedures, business practices, etc.) that are developed or
adopted by one or more voluntary consensus standards bodies. Examples
of organizations generally regarded as voluntary consensus standards
bodies include the American society for Testing and Materials (ASTM),
the National Fire Protection Association (NFPA), and the Society of
Automotive Engineers (SAE). The NTTAA requires Federal agencies like
EPA to provide Congress, through OMB, with explanations when an agency
decides not to use available and applicable voluntary consensus
standards. The final rule does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.
J. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing the rule and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. However, this action is not a major rule as defined by 5
U.S.C. 804(2). The final rule will be effective November 29, 2004.
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Hazardous
[[Page 69325]]
substances, Reporting and recordkeeping requirements.
Dated: November 18, 2004.
Michael O. Leavitt,
Administrator.
0
For the reasons set out in the preamble, part 63, title 40, chapter I
of the Code of Federal Regulations is amended as follows:
PART 63--[AMENDED]
0
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401, et seq.
Subpart C--[AMENDED]
0
2. Subpart C is amended by adding Sec. 63.63 to read as follows:
Sec. 63.63 Deletion of ethylene glycol monobutyl ether from the list
of hazardous air pollutants.
The substance ethylene glycol monobutyl ether (EGBE,2-
Butoxyethanol) (CAS Number 111-76-2) is deleted from the list of
hazardous air pollutants established by 42 U.S.C. 7412(b)(1).
[FR Doc. 04-26071 Filed 11-26-04; 8:45 am]
BILLING CODE 6560-50-P